(a) New Oral Anticoagulants & (b) Neuropathic Pain
|
|
- Paul Hopkins
- 8 years ago
- Views:
Transcription
1 Evidence Updates: (a) New Oral Anticoagulants & (b) Neuropathic Pain Brendalynn Ens, RN, MN, CCN(c) CADTH-Saskatchewan Gaetanne Murphy, BSc Pharm CADTH-Edmonton
2 CADTH s Programs HTA CDR Health Technology Assessment Common Drug Review = Assessment = Advice = Recommendation = User tools COMPUS Canadian Optimal Medication Prescribing and Utilization Service
3 What is a Health Technology? Any medical intervention utilized in health treatment and maintenance across the whole spectrum of medical and health practices. Designed to: Improve health Prevent, diagnose or treat disease Aid in rehabilitation or long term care Includes: Drugs and Vaccines Blood products Diagnostic tests Devices and equipment Medical and surgical procedures
4 Hierarchical Evidence Pyramid HTA
5 Additional CADTH Services Free access to reports: Drug Interventions Database: Rapid Response Service (Health Technology Inquiry Service) (self web access to database coming soon!) Local Liaison Officer support to aid interpretation of evidence, link with others pan-canadian, and place new requests for information
6
7 Evidence Update: Rivaroxaban and Dabigatran
8 Eriksson,I. et al (2003) EXPRESS Study; Journal of Thrombosis and Haemostasis Rosencher, et al (2005) ESCORTE Study: Journal of Thrombosis and Haemostasis Denby, A. (2008) London New Drugs Group NHS Canadian Joint Replacement Registry (CJRR) CIHI (2008) Annual Report: Hip & Knee Replacements in Canada Venous Thrombo- Embolism (VTE) Post-Surgical Risk Patients undergoing major orthopedic surgery elective total hip replacement (THR), elective total knee replacement (TKR), and hip fracture surgery (HFS) have elevated risk Without primary thromboprophylaxis, VTE has been reported to occur in: - 42% to 57% of patients undergoing THR - 41% to 85% of patients undergoing TKR - <35% to 50% of patients undergoing HFS (overall mortality highest) Of patients developing DVT, fatal PE has been reported in 0.1% to 2.0% of patients undergoing THR and 0.1% to 1.7% of patients undergoing TKR.
9 VTE Prevention Post-Orthopedic Surgery NOT Recommended prophylaxis options: Low dose unfractionated heparin Aspirin Graduated compression stocking Intermittent pneumatic compression (IPC) devices NOTE: IPC devices and venous foot pumps appear to provide some protection, but evidence is limited. They are also less effective than the anticoagulant alternatives. IPC devices should be used for patients with valid absolute contraindications to anticoagulants, and should be replaced with anticoagulant prophylaxis if/when contraindications resolve Thrombosis Interest Group of Canada (TIGC) (2009). Clinical Practice Guidelines
10 Thrombo-prophylaxis Post-Hip and Post-Knee surgery The following methods of thromboprophylaxis have been validated as effective choices for total hip or knee arthroplasty: A low molecular weight heparin (LMWH) once or twice daily SC dosing Warfarin in doses to prolong the INR to The pentasaccharide (fondaparinux) once daily SC dosing. A Direct thrombin inhibitor (dabigatran etexilate) once daily oral dosing. A Direct Xa inhibitor (rivaroxaban) once daily oral dosing. Thrombosis Interest Group of Canada (TIGC) (2009) Clinical Practice Guidelines
11 Newer Anticoagulants Dabigatran etexilate (Pradax Boehringer-Ingelheim) and rivaroxaban (Xarelto Bayer) are anticoagulants that were approved by Health Canada in 2008 for the prevention of VTE in patients who have undergone elective THR or TKR. Compared to other anticoagulants, dabigatran and rivaroxaban offer potential advantages fixed once-daily dosing oral administration rapid onset of action low potential for interactions with other drugs no requirement for ongoing anticoagulation monitoring.
12 Rivaroxaban No FDA Approval Medscape Cardiology (2008).
13
14
15 HTIS Search Results: Dabigatran DABIGATRAN One systematic review pooled results from RE-NOVATE, RE-MODEL, and RE- MOBILIZE (8,210 participants) revealed no statistically significant differences between dabigatran and enoxaparin in any of the end points that were used in the evaluation of safety or efficacy of thromboprophylaxis after THR or TKR Wolowacz SE, Roskell NS, Plumb JM, Caprini JA, Eriksson BI. Efficacy and safety of dabigatran etexilate for the prevention of venous thromboembolism following total hip or knee arthroplasty. A meta-analysis. Thromb Haemost 2009;101(1): Eriksson et al (2007); Eriksson et al (2007); Ginsberg et al (2009)
16 Dabigatran Bottom Line Of the published phase 3 trials, two showed the non-inferiority of dabigatran in the prevention of VTE after THR or TKR (RE-MODEL; RE-NOVATE), but the trial comparing dabigatran with the Health Canada-approved regimen for enoxaparin showed dabigatran to be Inferior (RE-MOBILIZE) As a result, the Canadian Expert Drug Advisory Committee (CEDAC) recommended that dabigatran not be listed in publicly funded drug plans. Additional trials comparing dabigatran with the Health Canadaapproved dose of enoxaparin are needed. Trkulja, V (2010). Meta-analysis CADTH CEDAC CDR Recommendation (2008)
17 Clinical Trial Phases Each phase of drug approval processes provides a piece of the knowledge puzzle Pre-clinical studies (in-vitro/test-tube) and (in-vivo / animal or cell culture) Phase 0 (first-in-humans trials; micro-dosing) Phase I (small N healthy volunteers; pharmacovigilance) - safety, tolerability, pharmacokinetics, pharmacodynamics Phase II (larger N; dosing requirements; and drug efficacy at prescribed doses) Phase III (randomized, multicentre trials; larger N; drug effectiveness) Phase IV (post-market surveillance; pharmacovigilance)
18 HTIS Search Results - Rivaroxaban Six RCT s: 3 phase 2 RCTs, and 3 phase 3RCTs evaluated rivaroxaban compared to enoxaparin Turpie et al (2005); Eriksson et al (2006); Eriksson et al (2006); Eriksson et al (2008); Kakkar et al (2008); Lassen et al (2008)
19 Rivaroxaban Bottom Line Results from three phase 3 trials indicate superior clinical effectiveness of rivaroxaban compared with enoxaparin for the prevention of VTE after THR or TKR. Based on these results, CEDAC recommended that rivaroxaban be listed in publicly funded drug plans for the prophylaxis of VTE after TKR or THR for up to two weeks as an alternative to LWMH. SASKATCHEWAN DRUG PLAN LISTING: rivaroxaban, tablet, 10mg (Xarelto-BAY) (a) For prophylaxis following total knee arthroplasty for up to 14 days following the procedure. (b) For prophylaxis in patients undergoing total hip replacement for up to 14 days following the procedure. Saskatchewan Drug Plan & Extended Benefits Branch; Online Formulary (Accessed April 28, 2010). Rivaroxaban CADTH-CEDAC CDR Recommendation (2008)
20 New Anticoagulant Research Limitations Patients with severe renal insufficiency, severe liver disease, or at high risk of bleeding were excluded from trials Low numbers of patients with a previous history of VTE, >age 75 years, or at extremities of weight were studied Studies only included patients 18 years and older Clinically important outcomes such as post-dvt complications, length of hospital stay, health related quality of life, and surgical outcomes were not assessed. Definitions of major bleeding events differed significantly between the dabigatran and rivaroxaban clinical trials There are no head-to-head trials comparing rivaroxaban with dabigatran, or comparing either drug directly to other anticoagulants. As a result, indirect comparisons within trials must be interpreted with caution because of differences in the methods for assessing outcomes There is no evidence to support the use of dabigatran or rivaroxaban in patients undergoing Hip fracture surgery
21 Case Study - Management of Neuropathic Pain
22 Neuropathic Pain Case Study RP, a 55 year old male, is one of your regular clients in your pharmacy. Medical history: Type 2 diabetes x 20 years Hypercholesterolemia x 10 years Osteoarthritis of the knee x 5 years Social history: 1.5 to 2 PPD smoker Occasional drinker BMI = 31.7
23 Neuropathic Pain Case Study Current Medications: Metformin 1000mg bid Atorvastatin 20mg daily ECASA 81mg daily Acetaminophen 1000mg qid Lab Work: A1c: 8.3% Total Cholesterol: 5.7mmol/L
24 Neuropathic Pain Case Study RP has prescription drug coverage through Social Assistance. He comes into the pharmacy today and explains to you that he just came from an appointment with his GP. He had been experiencing a sharp, stabbing pain in his feet, which was aggravated by walking. His GP told him that his symptoms were due to diabetic neuropathy. He presents a prescription for pregabalin 75mg twice daily.
25 Neuropathic Pain Case Study You determine that pregabalin has Exception Drug Status under the Saskatchewan Drug Plan as follows:
26 Neuropathic Pain Case Study You explain to RP that pregabalin is only covered as an exception drug, after a different medication is tried first and found to be ineffective or poorly tolerated. You further explain that the you could phone his doctor to recommend changing the medication to one that is covered or he can pay for pregabalin out of pocket. RP states that he cannot afford pregabalin and would like to try another medication that he does not have to pay for.
27 Pharmacological management of chronic neuropathic pain 1 1 Moulin et. al. Pharmacological management of chronic neuropathic pain - consensus statement and guidelines from the Canadian Pain Society. Pain Res Manag. 2007;12(1):13-21.
28 Neuropathic Pain Case Study Based on the Exception Drug Status guidelines for coverage and practice guidelines for Chronic Neuropathic Pain, you call RP s GP and recommend a trial of amitriptyline 10mg hs, increasing to a maximum of 150mg per day, based upon treatment response. RP s GP explains that much of his clinical experience in treating neuropathic pain is with pregabalin and asks how effective amitriptyline is in the management of neuropathic pain?
29 Where could you find the answer to this question?
30 Neuropathic Pain Case Study
31 Antidepressants for Neuropathic Pain Objective: To determine the analgesic effectiveness and adverse effects of antidepressant drugs in the treatment of neuropathic pain Methods: Systematic review of RCTs Antidepressants to placebo, other drugs or interventions Adults with neuropathic pain Outcomes: patient-reported improvement or pain relief, quality of life, adverse effects, sleep quality, or depression scores Meta-analysis Saarto T, Wiffen PJ. Antidepressants for neuropathic pain. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.:CD DOI: / CH pub2.
32 Antidepressants in Neuropathic Pain Results 61 RCTs involving 20 antidepressants (TCA, SSRI/SNRI, other) 26 parallel design, 35 cross-over studies 89% double blind 74% placebo controlled 28% diabetic neuropathy, 18% postherpetic neuralgia Central pain, atypical facial pain, HIV-related, mixed pain Placebo controlled studies had a higher median quality score than the active control studies
33 Antidepressants in Neuropathic Pain Tricyclic antidepressants (TCAs) 31 placebo controlled RCTs TCAs more effective than placebo for achieving moderate global improvement or pain relief TCAs: NNT 3.6 (95% CI 3.0 to 4.5) to achieve moderate pain relief Amitriptyline doses up to 150 mg daily: NNT 3.1 (2.5 to 4.2)
34
35 Antidepressants for Neuropathic Pain Diabetic neuropathy 13 RCTs evaluated pain 5 small studies, TCAs were more effective than placebo for achieving moderate global improvement or pain relief NNT 1.3 (95% CI 1.2 to 1.5)
36 Antidepressants in Neuropathic Pain
37 Antidepressants in Neuropathic Pain Adverse effects Major harm leading to study withdrawal Amitriptyline: NNH 28 (95% CI 17 to 68) Minor harm: drowsiness, dizziness, dry mouth, constipation etc Amitriptyline: NNH 6 (4.2 to 10.7)
38 Antidepressants in Neuropathic Pain Conclusions and Implications for Practice Antidepressants are effective for the treatment of neuropathic pain Best evidence of pain relief with TCAs and amitriptyline (NNT 3) Limited data of effectiveness of SSRIs Promising new data on venlafaxine Effectiveness is usually seen within a few days
39 Neuropathic Pain Case Study Based upon this report, what would you tell RP s GP about the effectiveness of amitriptyline in the management of neuropathic pain? What factors might you consider in applying the results of this report to RP? In addition to clinical effectiveness, what other factors may impact the selection of medication to manage RP s neuropathic pain?
40 Questions?
ABOUT XARELTO CLINICAL STUDIES
ABOUT XARELTO CLINICAL STUDIES FAST FACTS Xarelto (rivaroxaban) is a novel, oral direct Factor Xa inhibitor. On September 30, 2008, the European Commission granted marketing approval for Xarelto for the
More informationRandomized, double-blind, parallel-group, multicenter, doubledummy
ABOUT RECORD STUDIES FAST FACTS RECORD is a global program of four trials in more than 12,500 patients, comparing Xarelto (rivaroxaban) and enoxaparin in the prevention of venous thromboembolism (VTE)
More informationDATE: 06 May 2013 CONTEXT AND POLICY ISSUES
TITLE: Low Molecular Weight Heparins versus New Oral Anticoagulants for Long-Term Thrombosis Prophylaxis and Long-Term Treatment of DVT and PE: A Review of the Clinical and Cost-Effectiveness DATE: 06
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION RIVAROXABAN (Xarelto Bayer Inc.) New Indication: Pulmonary Embolism Note: The Canadian Drug Expert Committee (CDEC) previously reviewed rivaroxaban for the treatment of deep vein
More informationRivaroxaban for the prevention of venous thromboembolism: a single technology appraisal
DOI: 10.3310/hta13suppl3/07 Health Technology Assessment 2009; Vol. 13: Suppl. 3 Rivaroxaban for the prevention of venous thromboembolism: a single technology appraisal M Stevenson,* A Scope, M Holmes,
More informationPublished 2011 by the American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, IL 60018. AAOS Clinical Practice Guidelines Unit
Volume 4. AAOS Clinical Guideline on Preventing Venous Thromboembolic Disease in Patients Undergoing Elective Hip and Knee Arthroplasty Comparison with Other Guidelines Disclaimer This clinical guideline
More informationReview Article The Efficacy and Safety of Rivaroxaban for Venous Thromboembolism Prophylaxis after Total Hip and Total Knee Arthroplasty
Thrombosis Volume 2013, Article ID 762310, 5 pages http://dx.doi.org/10.1155/2013/762310 Review Article The Efficacy and Safety of Rivaroxaban for Venous Thromboembolism Prophylaxis after Total Hip and
More informationCardiovascular Disease
Cardiovascular Disease 1 Cardiovascular Disease 1. More target specific oral anticoagulants (TSOAC) 2. Vorapaxar (Zonivity) 3. Continued noise about a polypill 4. WATCHMAN 3 1 2 3 4 Left Atrial Appendage
More informationCommittee Approval Date: September 12, 2014 Next Review Date: September 2015
Medication Policy Manual Policy No: dru361 Topic: Pradaxa, dabigatran Date of Origin: September 12, 2014 Committee Approval Date: September 12, 2014 Next Review Date: September 2015 Effective Date: November
More informationRivaroxaban (Xarelto) for preventing venous thromboembolism after hip or knee replacement surgery
for preventing venous thromboembolism after hip or knee replacement surgery (riv-ah-rocks-ah-ban) Summary Rivaroxaban is an oral anticoagulant and the first direct factor Xa inhibitor. Rivaroxaban has
More informationDevang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical
Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical Center A.Fib affects 2.2 million Americans. The lifetime
More informationThe novel anticoagulants: entering a new era
Review article Peer reviewed article SWISS MED WKLY 2009;139(5 6):60 64 www.smw.ch 60 The novel anticoagulants: entering a new era Henri Bounameaux Division of Angiology and Haemostasis, Department of
More informationBreadth of indications matters One drug for multiple indications
Breadth of indications matters One drug for multiple indications Sylvia Haas, MD, PhD Formerly of the Technical University of Munich Munich, Germany Disclosures: Sylvia Haas 1 Novel oral anticoagulants:
More informationEvidence Review. New Oral Anticoagulants. Background. Search for non-cochrane reviews and RCTs.
Evidence Review Created on: October 01, 2009 Topic: New Oral Anticoagulants Background Elective total hip arthroplasty (THA) and total knee arthroplasty (TKA) are associated with a high risk of postoperative
More informationFailure or significant adverse effects to all of the alternatives: Eliquis and Xarelto
This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics
More informationThrombosis and Hemostasis
Thrombosis and Hemostasis Wendy Lim, MD, MSc, FRCPC Associate Professor, Department of Medicine McMaster University, Hamilton, ON Overview To review the important developments in venous thromboembolism
More informationThe Role of the Newer Anticoagulants
The Role of the Newer Anticoagulants WARFARIN = Coumadin DAGIBATRAN = Pradaxa RIVAROXABAN = Xarelto APIXABAN = Eliquis INDICATION DABIGATRAN (Pradaxa) RIVAROXABAN (Xarelto) APIXABAN (Eliquis) Stroke prevention
More informationEINSTEIN PE Data Summary & Perspectives on XARELTO (rivaroxaban) in ORS & NVAF. Recorded Webcast Update for Analysts and Investors March 26, 2012
EINSTEIN PE Data Summary & Perspectives on XARELTO (rivaroxaban) in ORS & NVAF Recorded Webcast Update for Analysts and Investors March 26, 2012 1 Webcast Presentation Agenda EINSTEIN PE Clinical Trial
More informationAre there sufficient indications for switching to new anticoagulant agents
Are there sufficient indications for switching to new anticoagulant agents Meyer Michel Samama et Gregoris Gerotziafas Groupe Hémostase-Thrombose Hôtel-Dieu, Hôpital Tenon, Paris & Biomnis Ivry/seine,
More informationHow To Take Xarelto
A patient's guide Your clinic's contact details are: Name: Contact number: Contents 2 Why have I been prescribed Xarelto? 2 What is Xarelto? 3 How do I take Xarelto? 3 What should I do if I miss a dose
More informationNew Oral Anticoagulants. How safe are they outside the trials?
New Oral Anticoagulants How safe are they outside the trials? Objectives The need for anticoagulant therapy Indications for anticoagulation Traditional anticoagulant therapies Properties of new oral anticoagulants
More informationUncontrolled when printed. Version 1.1. Acute Sector. Lead Author/Co-ordinator: Mr Simon Barker Consultant Orthopaedic Surgeon Julie Fraser
Acute Sector NHS Grampian Staff Local Treatment Protocol For Venous Thromoboembolic Prophylaxis Using Rivaroxaban 10mg Tablets In Adult Patients Undergoing Elective Hip Or Knee Replacement Surgery. Lead
More informationBios 6648: Design & conduct of clinical research
Bios 6648: Design & conduct of clinical research Section 1 - Specifying the study setting and objectives 1. Specifying the study setting and objectives 1.0 Background Where will we end up?: (a) The treatment
More informationDabigatran & Rivaroxaban Rat Poison in Better Packaging?
& Rat oison in Better ackaging? Declaration have no conflicts of interest to declare Rochelle M Gellatly BSc(harm), AR, harmd linical harmacy Specialist, ardiac Surgery St. aul s Hospital, rovidence Health
More informationTime of Offset of Action The Trial
New Antithrombotic Agents DISCLOSURE Relevant Financial Relationship(s) Speaker Bureau - None Consultant Amgen Tom DeLoughery, MD FACP FAWM Oregon Health and Sciences University What I am Talking About
More informationXARELTO (rivaroxaban tablets) in Knee and Hip Replacement Surgery
XARELTO (rivaroxaban tablets) in Knee and Hip Replacement Surgery Fast Facts: XARELTO is a novel, once-daily, oral anticoagulant recently approved in the United States for the prevention (prophylaxis)
More informationΣάββας Σουρμελής Διευθυντής Β Ορθοπαιδικής Κλινικής ΔΘΚΑ «Υγεία»
Σάββας Σουρμελής Διευθυντής Β Ορθοπαιδικής Κλινικής ΔΘΚΑ «Υγεία» 193s Heparin 194s 198s Low-molecularweight heparin Vitamin K antagonists 199s Direct thrombin inhibitors 22 Indirect Xa inhibitor 24 Oral
More informationRivaroxaban A new oral anti-thrombotic Dr. Hisham Aboul-Enein Professor of Cardiology Benha University 12/1/2012
Rivaroxaban A new oral anti-thrombotic Dr. Hisham Aboul-Enein Professor of Cardiology Benha University 12/1/2012 Agenda Ideal anticoagulant. Drawbacks of warfarin. Rivaroxaban in clinical trails. Present
More information5/21/2012. Perioperative Use Issues. On admission: During hospitalization:
Dabigatran and Rivaroxaban: Challenges in the Perioperative Setting Claudia Swenson, Pharm.D., CDE, BC-ADM, FASHP Central Washington Hospital Wenatchee, WA claudia.swenson@cwhs.com Dabigatran and Rivaroxaban:
More informationDabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism ERRATUM
Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism ERRATUM This report was commissioned by the NIHR HTA Programme as project number 12/78
More informationDabigatran vs rivaroxaban for thromboprophylaxis
Dabigatran vs rivaroxaban for thromboprophylaxis Dabigatran etexilate and rivaroxaban were both licensed recently for thromboprophylaxis following hip or knee surgery. In this article, the North Central
More informationPharmacological prophylaxis for venous thromboembolism
Pharmacological prophylaxis for venous thromboembolism Essence of this ArticleFor more than 20 years, routine preventive anticoagulant therapy has been the standard of care after major orthopaedic surgery.
More informationMedication Policy Manual. Topic: Eliquis, apixaban Date of Origin: July 12, 2013. Committee Approval Date: July 11, 2014 Next Review Date: July 2015
Medication Policy Manual Policy No: dru313 Topic: Eliquis, apixaban Date of Origin: July 12, 2013 Committee Approval Date: July 11, 2014 Next Review Date: July 2015 Effective Date: August 1, 2014 IMPORTANT
More informationCost Effectiveness of Apixaban (Eliquis ) for the Prevention of Venous Thromboembolic Events in Adult Patients who have Undergone Elective Total Hip
Cost Effectiveness of Apixaban (Eliquis ) for the Prevention of Venous Thromboembolic Events in Adult Patients who have Undergone Elective Total Hip Replacement or Total Knee Replacement National Centre
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationTA 256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation
Service Notification in response to DHSSPS endorsed NICE Technology Appraisals TA 256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation 1 Name of Commissioning
More informationTraditional anticoagulants
TEGH Family Practice Clinic Day April 4, 03 Use of Anticoagulants in 03: What s New (and What Isn t) Bill Geerts, MD, FRCPC Director, Thromboembolism Program, Sunnybrook HSC Professor of Medicine, University
More informationNew Anticoagulants for the Treatment of Thromboembolism With a little subplot on superficial thrombophlebitis. Mark Crowther
New Anticoagulants for the Treatment of Thromboembolism With a little subplot on superficial thrombophlebitis Mark Crowther 1 Disclosures Advisory Boards in last 24 months Pfizer, Alexion, Bayer, CSL Behring,
More informationHow To Treat Aneuricaagulation
Speaker Introduction Jessica Wilhoite, PharmD, BCACP Doctor of Pharmacy: Purdue University Postgraduate Residency Training: PGY1 Pharmacy Practice St. Vincent Hospital PGY2 Ambulatory Care St. Vincent
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION RIVAROXABAN (Xarelto Bayer Inc.) New Indication: Atrial Fibrillation, Stroke Prevention Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that rivaroxaban be
More informationTrust Guideline for Thromboprophylaxis in Trauma and Orthopaedic Inpatients
A clinical guideline recommended for use In: By: For: Key words: Department of Orthopaedics, NNUHT Medical staff Trauma & Orthopaedic Inpatients Deep vein thrombosis, Thromboprophylaxis, Orthopaedic Surgery
More informationTherapeutic Class Overview Oral Anticoagulants
Therapeutic Class Overview Oral Anticoagulants Therapeutic Class Overview/Summary: The oral anticoagulants, dabigatran etexilate mesylate (Pradaxa ), rivaroxaban (Xarelto ), and warfarin (Coumadin, Jantoven
More informationThree new/novel oral anticoagulants (NOAC) have been licensed in Ireland since 2008:
Key Points to consider when prescribing NOACs Introduction Three new/novel oral anticoagulants (NOAC) have been licensed in Ireland since 2008: Dabigatran Etexilate (Pradaxa ) 75mg, 110mg, 150mg. Rivaroxaban
More informationAdvanced Issues in Peri-Operative VTE Prevention
Advanced Issues in Peri-Operative VTE Prevention Michael-Anthony (M-A) Williams, M.D. Consultant Physician Centura Medical Consultants September 27th, 2012 Main Topics 1. The perils of the early mover-
More informationDVT/PE Management with Rivaroxaban (Xarelto)
DVT/PE Management with Rivaroxaban (Xarelto) Rivaroxaban is FDA approved for the acute treatment of DVT and PE and reduction in risk of recurrence of DVT and PE. FDA approved indications: Non valvular
More informationPreventing Blood Clots After Hip or Knee Replacement Surgery or Surgery for a Broken Hip. A Review of the Research for Adults
Preventing Blood Clots After Hip or Knee Replacement Surgery or Surgery for a Broken Hip A Review of the Research for Adults Is This Information Right for Me? Yes, if: You are considering or planning to
More informationNew Oral AntiCoagulants (NOAC) in 2015
New Oral AntiCoagulants (NOAC) in 2015 William R. Hiatt, MD Professor of Medicine and Cardiology University of Colorado School of Medicine President CPC Clinical Research Disclosures Received research
More informationPharmacoeconomic implications of thromboprophylaxis with new oral anticoagulants
Pharmacoeconomic implications of thromboprophylaxis with new oral anticoagulants after total hip or knee replacement in the United States Submitted to: Expert Opin Pharmacother Running head: Pharmacoeconomic
More informationVenous Thromboembolism: Long Term Anticoagulation. Dan Johnson, Pharm.D.
Venous Thromboembolism: Long Term Anticoagulation Dan Johnson, Pharm.D. Disclosures No financial relationships with products discussed Off-label use of drug therapy always discussed Objectives Review clinical
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationNew Anticoagulation Agents
New Anticoagulation Agents Use of New and Older Therapeutic Agents in the Treatment Regimen Michelle Geddes Case 1 40 year old woman with idiopathic proximal DVT. Previous heparin allergy (wheals, hives)
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 10 March 2010
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 10 March 2010 ARIXTRA 1.5 mg/0.3 ml, solution for injection in pre-filled syringe Box of 2 (CIP: 363 500-6) Box of
More information2.5mg SC daily. INR target 2-3 30 mg SC q 12 hr or 40mg daily. 10 mg PO q day (CrCl 30 ml/min). Avoid if < 30 ml/min. 2.
Anticoagulation dosing at UCDMC (SC=subcutaneously; CI=continuous infusion) Indication Agent Dose Comments Prophylaxis Any or No bleeding risk factors see adult heparin (VTE prophylaxis) IV infusion order
More informationNew Oral Anticoagulants: Topic Brief
New Oral Anticoagulants: Topic Brief June 9, 2015 High-Level Research Question In patients with nonvalvular atrial fibrillation (AF) or venous thromboembolic disease, or who have undergone surgery for
More informationNnEeWw DdEeVvEeLlOoPpMmEeNnTtSs IiıNn OoRrAaLl AaNnTtIiıCcOoAaGgUuLlAaTtIiıOoNn AaNnDd RrEeVvEeRrSsAaLl
NnEeWw DdEeVvEeLlOoPpMmEeNnTtSs IiıNn OoRrAaLl AaNnTtIiıCcOoAaGgUuLlAaTtIiıOoNn AaNnDd RrEeVvEeRrSsAaLl Mikele Wissing, RN June 2014 Introduction until recently, was the unrivaled medication for treatment
More informationFDA Approved Oral Anticoagulants
FDA Approved Oral Anticoagulants Generic (Trade Name) Warfarin (Coumadin, Jantoven ) 1 FDA approved indication Prophylaxis and treatment of venous thromboembolism (VTE) Prophylaxis and treatment of thromboembolic
More informationHERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) RIVAROXABAN RECOMMENDED see specific recommendations for licensed indications below
Name: generic (trade) Rivaroxaban (Xarelto ) HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) RIVAROXABAN RECOMMENDED see specific recommendations for licensed indications below What it is Indications
More information6/19/2012. Update on Venous Thromboembolism Prophylaxis. Disclosure. Learning Objectives. No conflicts of interest to declare
Update on Venous Thromboembolism Prophylaxis Disclosure No conflicts of interest to declare Learning Objectives After completion of this presentation, participants should be able to: Define venous thromboembolism,
More informationBayer Initiates Rivaroxaban Phase III Study to Support Dose Selection According to Individual Benefit-Risk Profile in Long- Term VTE Prevention
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Long-term prevention of venous blood clots (VTE): Bayer Initiates Rivaroxaban
More informationCommon Drug Review Pharmacoeconomic Review Report
Common Drug Review Pharmacoeconomic Review Report August 2015 Drug rivaroxaban (Xarelto) Indication Listing request Manufacturer Treatment of venous thromboembolic events (deep vein thrombosis [DVT], pulmonary
More informationPosition Statement: The Use of VTED Prophylaxis in Foot and Ankle Surgery
Position Statement: The Use of VTED Prophylaxis in Foot and Ankle Surgery Position Statement There is currently insufficient data for the (AOFAS) to recommend for or against routine VTED prophylaxis for
More information3/3/2015. Patrick Cobb, MD, FACP March 2015
Patrick Cobb, MD, FACP March 2015 I, Patrick Cobb, MD, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict
More informationReview of Non-VKA Oral AntiCoagulants (NOACs) and their use in Great Britain
Review of Non-VKA Oral AntiCoagulants (NOACs) and their use in Great Britain Dr Alexander (Ander) Cohen Guy s and St Thomas Hospitals, King s College London, UK Pavia Spring Meeting 13 June 2014 Overview
More informationRR 0.88 (95% CI: 0.77 1.00) P=0.051 (superiority) 3.75
ALL-CAUSE MORTALITY RR 0.88 (95% CI: 0.77 1.00) P=0.051 (superiority) Rate per year (%) 5.0 4.0 3.0 2.0 1.0 0 3.64 D150 mg BID 3.75 D110 mg BID RR 0.91 (95% CI: 0.80 1.03) P=0.13 (superiority) 4.13 Warfarin
More informationAPSR RESPIRATORY UPDATES
APSR RESPIRATORY UPDATES Volume 6, Issue 1 Newsletter Date: January 2014 APSR EDUCATION PUBLICATION Inside this issue: Venous thromboembolism Pulmonary embolism and deep vein thrombosis. 2 Outpatient versus
More information1/7/2012. Objectives. Epidemiology of Atrial Fibrillation(AF) Stroke in AF. Stroke Risk Stratification in AF
Objectives Atrial Fibrillation and Prevention of Thrombotic Complications: Therapeutic Update Andrea C. Flores Pharm.D Pharmacy Resident at the Miami VA Healthcare System Review the epidemiology, pathophysiology
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationNew Oral Anticoagulants Increase Risk for Gastrointestinal Bleeding - A Systematic Review and Meta-Analysis
New Oral Anticoagulants Increase Risk for Gastrointestinal Bleeding - A Systematic Review and Meta-Analysis Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ET Departments of Gastroenterology and Hepatology,
More informationEast Kent Prescribing Group
East Kent Prescribing Group Rivaroxaban (Xarelto ) Safety Information Approved by the East Kent Prescribing Group. Approved by: East Kent Prescribing Group (Representing Ashford CCG, Canterbury and Coastal
More informationSession 3 Topics. Argatroban. Argatroban. Drug Use and Adverse Effects. Laboratory Monitoring of Anticoagulant Therapy
~~Marshfield Labs Presents~~ Laboratory Monitoring of Anticoagulant Therapy Session 3 of 4 Michael J. Sanfelippo, M.S. Technical Director, Coagulation Services Session 3 Topics Direct Thrombin Inhibitors:
More informationTHE BENEFITS OF RIVAROXABAN (XARELTO ) ACROSS MULTIPLE INDICATIONS AND THE RELEVANCE TO CARDIOLOGISTS
THE BENEFITS OF RIVAROXABAN (XARELTO ) ACROSS MULTIPLE INDICATIONS AND THE RELEVANCE TO CARDIOLOGISTS Ingo Ahrens, Christoph Bode Cardiology and Angiology I, Heart Center Freiburg University, Freiburg,
More informationSummary Review. Newer Oral Anticoagulant Drugs
Summary Review Newer Oral Anticoagulant Drugs Final Original Report January 2013 The Agency for Healthcare Research and Quality has not yet seen or approved this report The purpose of reports is to make
More informationAnticoagulant therapy
Anticoagulation: The risks Anticoagulant therapy 1990 2002: 600 incidents reported 120 resulted in death of patient 92 deaths related to warfarin usage 28 reports related to heparin usage Incidents in
More informationRivaroxaban, an Oral, Direct Factor Xa Inhibitor: A New Option for Thromboprophylaxis
n Feature Article, an Oral, Direct Factor Xa Inhibitor: A New Option for Thromboprophylaxis Louis M. Kwong, MD, FACS abstract Full article available online at Healio.com/Orthopedics. Search: 20120525-38
More informationNew Treatments for Stroke Prevention in Atrial Fibrillation. John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013
New Treatments for Stroke Prevention in Atrial Fibrillation John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013 Classification Paroxysmal atrial fibrillation (AF) Last < 7
More informationCDEC RECORD OF ADVICE
CDEC RECORD OF ADVICE RIVAROXABAN (Xarelto Bayer Inc.) Indication: Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism This document summarizes the Canadian Drug Expert Committee (CDEC) response
More informationUpdate on Antiplatelets and anticoagulants. Outlines. Antiplatelets and Anticoagulants 1/23/2013. Timir Paul, MD, PhD
Update on Antiplatelets and anticoagulants Timir Paul, MD, PhD Antiplatelets Indications Doses Long term use (beyond 12 months) ASA and combination use of NSAIDS ASA resistance Plavix resistance Plavix
More informationNew Oral Anticoagulants
New Oral Anticoagulants Tracy Minichiello, MD Associate Professor of Medicine Chief, San FranciscoVA Anticoagulation and Thrombosis Service Ansell, J. Hematology Copyright 2010 American Society of Hematology.
More informationInvestor News. Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint. Not intended for U.S.
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint
More informationPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors
News Release For use outside the US and UK only Bayer Pharma AG 13342 Berlin Germany Tel. +49 30 468-1111 www.bayerpharma.com Bayer s Xarelto Approved in the EU for the Prevention of Stroke in Patients
More informationrivaroxaban 15 and 20mg film-coated tablets (Xarelto ) SMC No. (755/12) Bayer PLC
rivaroxaban 15 and 20mg film-coated tablets (Xarelto ) SMC No. (755/12) Bayer PLC 13 January 2012 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS
More informationPrior Authorization Guideline
Guideline Guideline Name Formulary Xarelto (rivaroxaban) UnitedHealthcare Community & State Approval Date 0/0/203 Revision Date 8//204 Technician Note: CPS Approval Date: /5/20; CPS Revision Date: 8/20/204
More informationKevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013
Kevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013 Family physician with Rivergrove Medical Clinic Practice in the north end since 1985 Medical Director of the Wellness
More informationAnticoagulation Dosing at UCDMC Indication Agent Standard Dose Comments and Dose Adjustments VTE Prophylaxis All Services UFH 5,000 units SC q 8 h
Indication Agent Standard Dose Comments and Dose Adjustments VTE Prophylaxis All Services UFH 5,000 units SC q 8 h See EMR adult VTE prophylaxis CI order set Enoxaparin See service specific dosing Assess
More informationAbbreviated Class Update: Anticoagulants. Month/Year of Review: July 2014 End date of literature search: June 2014
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationStepping Beyond Warfarin:
Stepping Beyond Warfarin: Working with Novel Oral Anticoagulants (NOACs) in Clinical Practice USAFP 2015 CPT Tyler R Reese, MD US Army, Medical Corps Tripler Army Medical Center Disclosures: Neither I,
More informationTo provide an evidenced-based approach to treatment of patients presenting with deep vein thrombosis.
DEEP VEIN THROMBOSIS: TREATMENT TARGET AUDIENCE: All Canadian health care professionals. OBJECTIVE: To provide an evidenced-based approach to treatment of patients presenting with deep vein thrombosis.
More informationClass Update: Anticoagulants (oral and injectable)
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION RIVAROXABAN (Xarelto Bayer Inc.) Indication: Stroke Prevention in Atrial Fibrillation This recommendation supersedes the Canadian Drug Expert Committee (CDEC) recommendation for
More informationComparison between New Oral Anticoagulants and Warfarin
Comparison between New Oral Anticoagulants and Warfarin Warfarin was the mainstay of oral anticoagulant therapy until the recent discovery of more precise targets for therapy. In recent years, several
More informationLong term anticoagulant therapy in patients with atrial fibrillation at high risk of stroke: a new scenario after RE-LY trial
Long term anticoagulant therapy in patients with atrial fibrillation at high risk of stroke: a new scenario after RE-LY trial Camillo Autore Università di Roma Sapienza II Facoltà di Medicina e Chirurgia
More informationClinical practice guideline for the prevention of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to
Clinical practice guideline for the prevention of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to Australian hospitals DRAFT FOR PUBLIC CONSULTATION 2009 Commonwealth
More informationNovel Oral Anticoagulants for Venous Thromboembolism Prophylaxis After Total Hip or Knee Replacement
Novel Oral Anticoagulants for Venous Thromboembolism Prophylaxis After Total Hip or Knee Replacement An Update on Rivaroxaban (Xarelto) Zachar y Stacy, PharmD, BCPS Key words: total hip replacement, total
More informationTraveller s Thrombosis. Dr. Peter Verhamme Vascular Medicine and Haemostasis UZ Leuven
Traveller s Thrombosis Dr. Peter Verhamme Vascular Medicine and Haemostasis UZ Leuven Case 1: To thromboprophylaxe or not Women, aged 49, BMI 29, Combined Oral Contraceptives. Family history of provoked
More informationManagement for Deep Vein Thrombosis and New Agents
Management for Deep Vein Thrombosis and New Agents Mark Malesker, Pharm.D., FCCP, FCCP, FASHP, BCPS Professor of Pharmacy Practice and Medicine Creighton University 5 th Annual Creighton Cardiovascular
More information2. Background This indication of rivaroxaban had not previously been considered by the PBAC.
PUBLIC SUMMARY DOCUMENT Product: Rivaroxaban, tablets, 15mg and 20mg, Xarelto Sponsor: Bayer Australia Ltd Date of PBAC Consideration: March 2013 1. Purpose of Application The application requested the
More informationPulmonary Embolism Treatment Update
UC SF Pulmonary Embolism Treatment Update Jeffrey Tabas, MD Professor UCSF School of Medicine Emergency Department San Francisco General Hospital sf g h Disclosure No Financial Relationships to Disclose
More informationMCHENRY WESTERN LAKE COUNTY EMS SYSTEM OPTIONAL CE ADVANCED LEVEL (EMTP, PHRN, ECRN) August 2013. Anticoagulants
MCHENRY WESTERN LAKE COUNTY EMS SYSTEM OPTIONAL CE ADVANCED LEVEL (EMTP, PHRN, ECRN) August 2013 Anticoagulants Anticoagulants are agents that prevent the formation of blood clots. Before we can talk about
More information